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Collateral damage has been reported with use of the cryoballoon for pulmonary vein isolation.

The purpose of this study was to determine the incidence and characteristics associated with atrioesophageal fistula (AEF) after cryoballoon use.

Cases of AEF reported with use of the cryoballoon since 2011 were collected from the Manufacturer and User Facility Device Experience (MAUDE) database, publications, and the manufacturer’s database. Lowest balloon temperatures were compared with matched control patients undergoing cryoballoon ablation without AEF formation. Location of AEF was compared with AEF associated with radiofrequency ablation.

A total of 11 cases of AEF were identified from a worldwide experience that exceed 120,000 cases. Mean age was 60 (range 31–78 years), and 80% of patients were male. Although mean lowest balloon temperatures were no …