The literature publication reported the following patient complications during a cryo ablation procedure: multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.There was one (1) patient that experienced a tamponade, one (1) patient experienced a thromboembolic event, seven (7) patients had phrenic nerve injury with recovery, seven (7) patients had vascular bleeds, one (1) patient had gastroparesis, one (1) patient had an esophageal ulcer and two (2) patients had hemoptysis.The status/location of the devices were unknown.No further patient complications have been reported as a result of this event.
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