BTG Visual-ICE - Potential Adverse Events

Visual-ICE™ Cryoablation System
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1.8 Potential Adverse Events
Potential adverse events which may be associated with the use of cryoablation may be organ
specic or general and may include, but are not limited to abscess, adjacent organ injury,
allergic/anaphylactoid reaction, angina/ coronary ischemia, arrhythmia, atelectasis, bladder neck
contracture, bladder spasms, bleeding/hemorrhage, creatinine elevation, creation of false urethral
passage, cystitis, death, deep vein thrombosis (DVT), delayed/non healing, diarrhea, disseminated
intravascular coagulation (DIC), ecchymosis, edema/swelling, ejaculatory dysfunction, erectile
dysfunction (organic impotence), fever, stula, genitourinary perforation, glomerular ltration rate
elevation, hematoma, hematuria, hypertension, hypotension, hypothermia, idiosyncratic reaction,
ileus, impotence, infection, injection site reaction, myocardial infarction, nausea, neuropathy,
obstruction, organ failure pain, pelvic pain, pelvic vein thrombosis, penile tingling/numbness,
perirenal uid collection, pleural e󰀨usion, pneumothorax, probe site paresthesia, prolonged chest tube
drainage, prolonged intubation, pulmonary embolism, pulmonary insu󰀩ciency / failure, rectal
pain, rectourethral stula, renal artery/renal vein injury, renal capsule fracture, renal failure, renal
hemorrhage, renal infarct, renal obstruction, renal vein thrombosis, scrotal edema, sepsis, skin burn/
frostbite, stricture of the collection system or ureters, stroke, thrombosis/thrombus/embolism, transient
ischemic attack, tumor seeding, UPJ obstruction/injury, urethral sloughing, urethral stricture,
urinary stula, urinary frequency/urgency, urinary incontinence, urinary leak, urinary renal leakage,
urinary retention/oliguria, urinary tract infection, vagal reaction, voiding complication including irritative
voiding symptoms, vomiting, wound complication, and wound infection.