Trial Outcomes & Findings for NOLA (NeuWave Observational Liver Ablation) Registry (NCT NCT04107766)

Last Updated: 2026-04-17

Results Overview

Technique efficacy is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray at Visit 3 (between 7 days and less than 3 months post-ablation).

Recruitment status

TERMINATED

Target enrollment

1254 participants

Primary outcome timeframe

Between 7 days and less than 3 months post-ablation

Results posted on

2026-04-17

Participant Flow

1254 participants enrolled in the study. 1 participant withdrew from the study, 1 participant discontinued, and 49 of these participants were later screen failures as they did not meet all inclusion/exclusion criteria. 1203 participants were treated with the NeuWave microwave ablation device.

Participant milestones

Participant milestones
Measure	Population Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Overall Study STARTED	1203
Overall Study COMPLETED	83
Overall Study NOT COMPLETED	1120

Reasons for withdrawal

Reasons for withdrawal
Measure	Population Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Overall Study Study stopped by sponsor	750
Overall Study Adverse Event	3
Overall Study Death	213
Overall Study Lost to Follow-up	53
Overall Study Physician Decision	9
Overall Study Site closed by sponsor	12
Overall Study Withdrawal by Subject	18
Overall Study Other	62

Baseline Characteristics

NOLA (NeuWave Observational Liver Ablation) Registry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Population n=1203 Participants Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Age, Continuous	64.4 Years STANDARD_DEVIATION 10.7 • n=130 Participants
Sex: Female, Male Female	376 Participants n=130 Participants
Sex: Female, Male Male	827 Participants n=130 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	76 Participants n=130 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	929 Participants n=130 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	198 Participants n=130 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=130 Participants
Race/Ethnicity, Customized Asian	238 Participants n=130 Participants
Race/Ethnicity, Customized Black or African American	34 Participants n=130 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	2 Participants n=130 Participants
Race/Ethnicity, Customized White	751 Participants n=130 Participants
Race/Ethnicity, Customized Multiple	2 Participants n=130 Participants
Race/Ethnicity, Customized Not Reported	141 Participants n=130 Participants
Race/Ethnicity, Customized Other	32 Participants n=130 Participants
Number of Target Lesions per Participant 1 Lesion	970 Participants n=130 Participants
Number of Target Lesions per Participant 2 Lesions	158 Participants n=130 Participants
Number of Target Lesions per Participant 3 Lesions	55 Participants n=130 Participants
Number of Target Lesions per Participant 4 Lesions	12 Participants n=130 Participants
Number of Target Lesions per Participant 5 or More Lesions	8 Participants n=130 Participants

PRIMARY outcome

Timeframe: Immediately post-ablation (Day 0)

Population: Technical Success outcome was reported for 1198 participants.

Technical Success is defined as ablation of the target lesion(s) according to the protocol and covered completely, with an adequate margin (that is, the ablation zone completely overlaps or encompasses the target lesion(s) plus an ablative margin), as defined by the performing physician who will make the assessment using CT, MRI, PET, US, and/or X-ray, immediately following the procedure.

Outcome measures

Outcome measures
Measure	Population n=1198 Participants Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Number of Patients Whose Ablation Resulted in Technical Success Yes	1174 Participants
Number of Patients Whose Ablation Resulted in Technical Success No	24 Participants

PRIMARY outcome

Timeframe: Between 7 days and less than 3 months post-ablation

Population: Technique Efficacy outcome was reported for 1053 participants.

Outcome measures

Outcome measures
Measure	Population n=1053 Participants Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Number of Patients Whose Ablation Resulted in Technique Efficacy Yes	1000 Participants
Number of Patients Whose Ablation Resulted in Technique Efficacy No	53 Participants

PRIMARY outcome

Timeframe: Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation.

Population: Kaplan-Meier probability of Target lesion recurrence at specified time point.

Target lesion recurrence (local recurrence) was evaluated at every visit after ablation of the target lesion(s) and assessed by CT, MRI, PET, US, and/or X-ray.

Outcome measures

Outcome measures
Measure	Population n=1203 Participants Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Target Lesion Recurrence Rate At 6 month follow up	4.69 Percent Probability Interval 3.51 to 6.25
Target Lesion Recurrence Rate At 12 month follow up	10.05 Percent Probability Interval 8.24 to 12.23
Target Lesion Recurrence Rate At 18 month follow up	14.36 Percent Probability Interval 12.12 to 16.98
Target Lesion Recurrence Rate At 24 month follow up	17.14 Percent Probability Interval 14.63 to 20.04
Target Lesion Recurrence Rate At 30 month follow up	19.94 Percent Probability Interval 17.09 to 23.19
Target Lesion Recurrence Rate At 36 month follow up	21.44 Percent Probability Interval 18.39 to 24.92
Target Lesion Recurrence Rate At 42 month follow up	25.52 Percent Probability Interval 21.73 to 29.84
Target Lesion Recurrence Rate At 48 month follow up	27.42 Percent Probability Interval 23.22 to 32.2
Target Lesion Recurrence Rate At 54 month follow up	29.72 Percent Probability Interval 24.72 to 35.47
Target Lesion Recurrence Rate At 60 month follow up	31.57 Percent Probability Interval 26.71 to 38.38

SECONDARY outcome

Timeframe: Assessed at 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, and 60 months post-ablation.

Population: Kaplan-Meier probability of Overall survival at specified time point.

Overall survival was evaluated at every visit after ablation of the target lesion(s)

Outcome measures

Outcome measures
Measure	Population n=1203 Participants Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Overall Survival At 6 month follow up	98.27 Percent Probability Interval 97.34 to 98.88
Overall Survival At 12 month follow up	95.12 Percent Probability Interval 93.66 to 96.25
Overall Survival At 18 month follow up	89.96 Percent Probability Interval 87.91 to 91.69
Overall Survival At 24 month follow up	84.66 Percent Probability Interval 82.14 to 86.84
Overall Survival At 30 month follow up	81.42 Percent Probability Interval 78.65 to 83.87
Overall Survival At 36 month follow up	77.77 Percent Probability Interval 74.69 to 80.53
Overall Survival At 42 month follow up	74.86 Percent Probability Interval 71.44 to 77.94
Overall Survival At 48 month follow up	71.50 Percent Probability Interval 67.51 to 75.09
Overall Survival At 54 month follow up	68.14 Percent Probability Interval 63.25 to 72.52
Overall Survival At 60 month follow up	68.14 Percent Probability Interval 63.25 to 72.52

Adverse Events

Population

Serious events: 488 serious events

Other events: 398 other events

Deaths: 213 deaths

Serious adverse events

Serious adverse events
Measure	Population n=1203 participants at risk Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Blood and lymphatic system disorders Anaemia	0.91% 11/1203 • Number of events 13 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Blood loss anaemia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Febrile neutropenia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Immune thrombocytopenia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Neutropenia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Pancytopenia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Splenic haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Splenic infarction	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Blood and lymphatic system disorders Thrombocytopenia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Acute myocardial infarction	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Angina pectoris	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Atrial fibrillation	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Atrial flutter	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Atrial thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Atrioventricular block	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Bradycardia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Cardiac arrest	0.33% 4/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Cardiac failure	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Cardiac failure congestive	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Cardio-respiratory arrest	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Cardiomyopathy	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Chronic left ventricular failure	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Myocardial infarction	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Myocardial ischaemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Pericardial effusion	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Right ventricular failure	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Sinus tachycardia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Tachycardia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Cardiac disorders Ventricular tachycardia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Ear and labyrinth disorders Vertigo	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Endocrine disorders Adrenal insufficiency	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Eye disorders Amaurosis fugax	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Eye disorders Retinal artery occlusion	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal distension	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal hernia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal pain	2.2% 27/1203 • Number of events 27 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal pain lower	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal pain upper	1.00% 12/1203 • Number of events 14 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Ascites	1.2% 15/1203 • Number of events 16 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Chronic gastritis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Colitis ischaemic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Constipation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Diarrhoea	0.83% 10/1203 • Number of events 10 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Duodenal perforation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Duodenal ulcer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Duodenal ulcer perforation	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Enteritis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Enterocolitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Enterocutaneous fistula	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Erosive oesophagitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastric perforation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastric varices	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastric varices haemorrhage	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastrointestinal disorder	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.75% 9/1203 • Number of events 12 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Gastrointestinal oedema	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Haematemesis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Haematochezia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Ileus	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Ileus paralytic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Incarcerated inguinal hernia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Intestinal ischaemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Intestinal obstruction	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Intestinal perforation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Intra-abdominal fluid collection	0.33% 4/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Intra-abdominal haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Large intestine perforation	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Melaena	0.67% 8/1203 • Number of events 8 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Nausea	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Obstruction gastric	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Obstructive pancreatitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Oesophageal perforation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Oesophageal varices haemorrhage	0.50% 6/1203 • Number of events 6 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Oesophagitis ulcerative	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Pancreatitis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Pancreatitis acute	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Pancreatitis relapsing	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Portal hypertensive gastropathy	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Proctalgia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Rectal haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Rectal ulcer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Salivary gland calculus	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Small intestinal obstruction	0.83% 10/1203 • Number of events 14 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Small intestinal perforation	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Spigelian hernia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Swollen tongue	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.67% 8/1203 • Number of events 8 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Varices oesophageal	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Vomiting	0.67% 8/1203 • Number of events 8 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Adverse drug reaction	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Application site haematoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Asthenia	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Catheter site pain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Chest discomfort	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Chest pain	0.67% 8/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Chills	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Death of unknown cause	4.2% 51/1203 • Number of events 51 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Disease progression	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Drug withdrawal syndrome	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Effusion	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Fatigue	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders General physical health deterioration	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Generalised oedema	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Incarcerated hernia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Inflammation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Malaise	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Multiple organ dysfunction syndrome	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Necrosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Non-cardiac chest pain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Oedema	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Oedema peripheral	0.25% 3/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Peripheral swelling	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Physical deconditioning	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Pneumatosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Pyrexia	3.0% 36/1203 • Number of events 38 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Systemic inflammatory response syndrome	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Ulcer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Bile duct stenosis	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Bile duct stone	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Biliary dilatation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Biliary ischaemia	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Biliary obstruction	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholangitis	0.33% 4/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholangitis acute	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholecystitis	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholecystitis acute	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholelithiasis	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cholestasis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Chronic hepatic failure	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Cirrhosis alcoholic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Dilatation intrahepatic duct acquired	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Gallbladder rupture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Haemobilia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic artery stenosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic cirrhosis	1.1% 13/1203 • Number of events 13 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic failure	0.83% 10/1203 • Number of events 10 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic haematoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatic vein thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hepatorenal syndrome	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Hyperbilirubinaemia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Jaundice	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Jaundice cholestatic	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Liver disorder	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Liver injury	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Perihepatic discomfort	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Portal vein thrombosis	0.91% 11/1203 • Number of events 12 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Portosplenomesenteric venous thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Hepatobiliary disorders Subcapsular hepatic haematoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Immune system disorders Anaphylactic reaction	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Immune system disorders Contrast media reaction	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Immune system disorders Liver transplant rejection	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Immune system disorders Transplant rejection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Abdominal abscess	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Abdominal infection	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Appendicitis perforated	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Arthritis bacterial	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Atypical pneumonia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Bacteraemia	0.25% 3/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Bacterial sepsis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Bacteroides infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Biliary sepsis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Biliary tract infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Biloma infected	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Bronchitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations COVID-19	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations COVID-19 pneumonia	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Cellulitis	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Clostridium bacteraemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Clostridium difficile colitis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Clostridium difficile infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Cystitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Cystitis escherichia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Device related sepsis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Empyema	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Endocarditis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Endocarditis bacterial	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Enterobacter infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Enterococcal bacteraemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Enterocolitis infectious	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Escherichia bacteraemia	0.25% 3/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Escherichia infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Gastroenteritis salmonella	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Gastroenteritis viral	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Haematoma infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Infected dermal cyst	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Infected fistula	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Infective thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Injection site abscess	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Intervertebral discitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Klebsiella bacteraemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Klebsiella infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Liver abscess	0.83% 10/1203 • Number of events 11 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Localised infection	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Lower respiratory tract infection	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Medical device site infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Meningitis cryptococcal	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Neutropenic sepsis	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Norovirus infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Osteomyelitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Paraspinal abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Parotid abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Parotitis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pelvic abscess	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pelvic infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pelvic sepsis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Perihepatic abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Perirectal abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Peritonitis	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Peritonitis bacterial	1.00% 12/1203 • Number of events 14 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Periumbilical abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pneumonia	1.4% 17/1203 • Number of events 17 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pneumonia bacterial	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Pneumonia klebsiella	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Postoperative wound infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Respiratory tract infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Scrotal infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Sepsis	1.5% 18/1203 • Number of events 19 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Septic shock	1.00% 12/1203 • Number of events 13 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Skin infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Staphylococcal sepsis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Streptococcal bacteraemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Subcutaneous abscess	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Superinfection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Systemic candida	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Urinary tract infection	0.91% 11/1203 • Number of events 13 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Urosepsis	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Viral infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Infections and infestations Wound infection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Accidental overdose	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Autonomic dysreflexia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Biliary anastomosis complication	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Diaphragmatic injury	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Fall	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Femoral neck fracture	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Femur fracture	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Foreign body	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Gastroenteritis radiation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Gastrointestinal stoma complication	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Head injury	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Hip fracture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Humerus fracture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Incisional hernia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Ligament sprain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Limb injury	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Lower limb fracture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post ablation syndrome	1.00% 12/1203 • Number of events 12 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post embolisation syndrome	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post procedural bile leak	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post procedural fever	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post procedural haematoma	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Procedural haemorrhage	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Procedural hypertension	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Procedural pain	0.58% 7/1203 • Number of events 7 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Procedural pneumothorax	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Rib fracture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Road traffic accident	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Seroma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Stoma obstruction	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Stomal hernia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Thermal burn	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Toxicity to various agents	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Transplantation complication	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Ulna fracture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Wound	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Wound evisceration	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Blood bilirubin increased	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations C-reactive protein increased	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Cardiac telemetry abnormal	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Hepatic enzyme increased	0.42% 5/1203 • Number of events 7 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Liver function test abnormal	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Liver function test increased	0.58% 7/1203 • Number of events 7 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Investigations Oxygen saturation decreased	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Adult failure to thrive	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Dehydration	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Diabetes mellitus	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Electrolyte imbalance	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Failure to thrive	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Fluid overload	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Gout	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hypercalcaemia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hyperglycaemia	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hyperkalaemia	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hypocalcaemia	0.17% 2/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hypoglycaemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hypokalaemia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Hyponatraemia	0.67% 8/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Metabolism and nutrition disorders Lactic acidosis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Arthralgia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Back pain	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Bone lesion	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Fistula	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Haemarthrosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Muscular weakness	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Osteoarthritis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Pathological fracture	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Spinal osteoarthritis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder neoplasm	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bone cancer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Brain cancer metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cardiac myxoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cholangiocarcinoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon adenoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer recurrent	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer stage IV	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer metastatic	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic cancer metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.75% 9/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung cancer metastatic	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm of ampulla of Vater	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	1.7% 20/1203 • Number of events 20 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to bone	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lymph nodes	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.91% 11/1203 • Number of events 11 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal carcinoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer metastatic	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Salivary gland cancer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Small intestine carcinoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour associated fever	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour invasion	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cauda equina syndrome	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cerebral haematoma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cerebral haemorrhage	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cerebral infarction	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cerebrovascular accident	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Cognitive disorder	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Diabetic coma	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Dizziness	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Encephalopathy	0.58% 7/1203 • Number of events 8 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Epilepsy	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Haemorrhage intracranial	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Hepatic encephalopathy	2.6% 31/1203 • Number of events 46 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Intracranial aneurysm	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Intraventricular haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Ischaemic stroke	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Lethargy	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Malignant spinal cord compression	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Metabolic encephalopathy	0.58% 7/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Neurological symptom	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Paraparesis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Partial seizures	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Sciatica	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Seizure	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Subarachnoid haemorrhage	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Syncope	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Thalamic infarction	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Nervous system disorders Transient ischaemic attack	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Product Issues Device dislocation	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Alcohol withdrawal syndrome	0.17% 2/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Completed suicide	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Confusional state	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Delirium	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Depression suicidal	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Psychiatric disorders Mental status changes	0.75% 9/1203 • Number of events 11 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Acute kidney injury	2.2% 27/1203 • Number of events 31 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Calculus urinary	0.08% 1/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Haematuria	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Hydronephrosis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Prerenal failure	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Renal failure	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Renal and urinary disorders Urinary retention	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.83% 10/1203 • Number of events 10 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Chylothorax	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Diaphragmatic rupture	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.67% 8/1203 • Number of events 9 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Hepatic hydrothorax	0.25% 3/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Hypercapnia	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.42% 5/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Organising pneumonia	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pleural effusion	1.4% 17/1203 • Number of events 17 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pleural fistula	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	0.25% 3/1203 • Number of events 3 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pneumothorax	1.9% 23/1203 • Number of events 25 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.58% 7/1203 • Number of events 7 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Angioedema	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Diabetic foot	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Pruritus	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Rash	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Skin ulcer	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Skin and subcutaneous tissue disorders Subcutaneous emphysema	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Aortic stenosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Arterial haemorrhage	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Arterial occlusive disease	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Artery dissection	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Bleeding varicose vein	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Circulatory collapse	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Deep vein thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Embolism arterial	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Haematoma	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Haemorrhage	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Hypertension	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Hypotension	0.33% 4/1203 • Number of events 5 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Orthostatic hypotension	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Pelvic venous thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Peripheral artery stenosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Peripheral venous disease	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Shock haemorrhagic	0.33% 4/1203 • Number of events 4 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Thrombosis	0.17% 2/1203 • Number of events 2 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Vascular disorders Vena cava thrombosis	0.08% 1/1203 • Number of events 1 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.

Other adverse events

Other adverse events
Measure	Population n=1203 participants at risk Patients with at least one soft-tissue liver lesion ablated with the NEUWAVE Microwave Ablation System or NEUWAVE Microwave Ablation System with Ablation Confirmation.
Injury, poisoning and procedural complications Procedural pain	8.9% 107/1203 • Number of events 116 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal pain	8.2% 99/1203 • Number of events 102 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Nausea	4.4% 53/1203 • Number of events 53 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Musculoskeletal and connective tissue disorders Arthralgia	4.2% 50/1203 • Number of events 53 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
General disorders Pyrexia	2.6% 31/1203 • Number of events 32 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Gastrointestinal disorders Abdominal pain upper	2.5% 30/1203 • Number of events 33 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.
Injury, poisoning and procedural complications Wound secretion	2.3% 28/1203 • Number of events 28 • 5 years following the initial ablation procedure. Participants were evaluated for Adverse Events (AEs) at every study visit. Per protocol, all Serious Adverse Events (SAEs) were collected, and AEs deemed to have an unlikely, possible, probable, or causal relationship to the study procedure or device were collected in the study database.

Additional Information

Erin Meyers

Ethicon

Phone: 937-681-0322

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place