Background: Real-world clinical data on the adverse events related to the use of cryoballoon catheter for pulmonary vein isolation remains limited.
Objective: To report and describe the adverse events related to the use of Artic Front cryoballoon catheters (Arctic Front, Arctic Front Advance, and Arctic Front Advance Pro) reported in the Food and Drug Administration's (FDA) Manufacturers and User Defined Experience (MAUDE) database.
Methods: We reviewed all the adverse events reported to the FDA MAUDE database over a 10.