Adverse events in cryoballoon ablation for pulmonary vein isolation: Insight from the Food and Drug Administration Manufacturer and User Facility Device Experience

Abstract Background Real‐world clinical data on the adverse events related to use of cryoballoon catheter for pulmonary vein isolation remains limited. Objective To report and describe Artic Front catheters (Arctic Front, Arctic Advance, Advance Pro) reported in Food Drug Administration's (FDA) Manufacturers User Defined Experience (MAUDE) database. Methods We reviewed all FDA MAUDE database over a 10.7‐year study period from January 01, 2011 September 31, 2021. All were independently by two physicians. Results During period, total 320 procedural‐related identified. The most common event was transient or persistent phrenic nerve palsy (PNP), accounting 48% events. This followed cardiac perforation (15%), stenosis (8%), ischemic attack stroke (6%), vascular injury (4%), ST‐elevation myocardial infarction (3%), hemoptysis (2%), pericarditis esophageal ulcer fistula (1%). There six intra‐procedural death as result perforation. Conclusion procedural associated with ablation PNP cases mortality due