Event summary: it was reported that one day post cryo ablation procedure, the patient experienced atypical chest pain, and was diagnosed with gastroesophageal reflux disease (gerd).Additionally, the patient had complaints of neck pain, difficulty swallowing and coughing bouts.It was also reported that the patient had hypotension.The balloon catheter was not returned for investigation.There is no indication of the reported adverse events is related to manufacturing and performance of the device.In conclusion, this is a case related to a clinical adverse event (chest pain, neck pain, cough, hypotension and difficult swallowing and digestive discomfort).The reported adverse events could not be related to the performance of the cryoablation devices.The balloon catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
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It was reported that one day post cryo ablation procedure, the patient experienced atypical chest pain, and also was diagnosed with gastroesophageal reflux disease (gerd).Additionally, the patient had complaints of neck pain, difficulty swallowing and coughing bouts.It was also reported that the patient had hypotension.The case was already completed with cryo.The patient was subsequently started on an anti-inflammatory with a proton pump inhibitor, and a modification to his current medication regimen was performed.The patient had an extended hospitalization.The patient's symptoms then resolved, and the patient was discharged from the hospital.No further patient complications have been reported as a result of this event.The patient was part of the (b)(6) clinical study.
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